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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CYBERONICS, INC. PULSE GEN MODEL 102

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CYBERONICS, INC. PULSE GEN MODEL 102 Back to Search Results
Model Number 102
Event Date 10/01/2007
Event Type  Injury  
Event Description

It was reported that the vns patient underwent a surgery for explantation of the device due to an infection. It was reported that the generator and the lead were both explanted. Follow up with the physician revealed that the patient's implant surgery was in (b) (6) 2007, the patient had developed an infection. Cultures were taken prior to the explantation surgery and the results revealed a "+" infection confirming the event. The explant surgery took place in (b) (6) 2007. In addition, physician's office notes revealed that the patient had also developed an allergic reaction, and dehiscence wound following the implant surgery. Further follow up with the physician revealed that all the events occurred due to the patient picking at his wound. The explanted products were returned to the manufacturer and product analyses have been completed. No anomalies were identified with the products that could have contributed to the reported event. The patient was recently implanted with a brand new device.

 
Manufacturer Narrative

Device manufacturing records were reviewed. Review of manufacturing records confirmed sterilization for both the generator and lead prior to distribution.

 
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Brand NamePULSE GEN MODEL 102
Manufacturer (Section D)
CYBERONICS, INC.
houston TX 77058
Manufacturer Contact
nydia grimes
100 cyberonics blvd.
ste. 600
houston , TX 77058
2812287200
MDR Report Key1590826
Report Number1644487-2010-00192
Device Sequence Number1
Product CodeLYJ
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 12/28/2009
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/27/2010
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator LAY USER/PATIENT
Device EXPIRATION Date09/30/2008
Device MODEL Number102
Device LOT Number016250
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer01/21/2008
Is The Reporter A Health Professional? Yes
Date Manufacturer Received12/28/2009
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured11/01/2006
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 01/27/2010 Patient Sequence Number: 1
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